US20130310750A1 - Safety needle - Google Patents
Safety needle Download PDFInfo
- Publication number
- US20130310750A1 US20130310750A1 US13/896,026 US201313896026A US2013310750A1 US 20130310750 A1 US20130310750 A1 US 20130310750A1 US 201313896026 A US201313896026 A US 201313896026A US 2013310750 A1 US2013310750 A1 US 2013310750A1
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- United States
- Prior art keywords
- stylet
- cannula
- pusher
- distal end
- tubular
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A61M1/008—
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/04—Artificial pneumothorax apparatus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
- A61B17/3496—Protecting sleeves or inner probes; Retractable tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0643—Devices having a blunt needle tip, e.g. due to an additional inner component
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3474—Insufflating needles, e.g. Veress needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M2005/3212—Blunting means for the sharp end of the needle
Definitions
- the present invention relates to treatment of medical conditions such as tension pneumothorax and particularly to a device for its treatment.
- the U.S. military services currently prescribe needle decompression for treatment of tension pneumothorax, a condition which can be fatal if not quickly relieved.
- the means of treatment for prehospital care should be compact and as simple as practical.
- the needle prescribed by the military services is sharp, creating the possibility of damaging underlying organs after initial penetration through the chest wall. It has been reported as well that the needle occasionally plugs with a tissue “core” as it travels through the chest wall. If the plug is detected, the needle could be flushed using a syringe; however it is not certain that the plug would be detected.
- a 3.15 inch long, 14 gauge angiocatheter needle is used as the standard of care for the U.S. military. Although the catheter is 14 gauge (0.083′′ diameter), the inner diameter is 0.058′′, and the needle outer and inner diameters are 0.058′′ and 0.042′′ respectively. This small inner diameter of 0.042′′ does not provide an effective means for venting pressurized air quickly from the pleural space.
- the Veress needle is a special needle used in laparoscopic surgical procedures.
- a conventional Veress needle consists of a hollow outer cannula ground obliquely to a sharp point at a distal end, and terminating in a plastic housing at the opposite proximal end.
- a hollow tube that has a blunt tip at its distal end (common to the sharp tip of the outer cannula), and that is axially spring-biased in a distal direction by a spring contained in the plastic housing.
- the spring bias forces the hollow inner tube to protrude just beyond the sharp tip of the outer cannula, obscuring the sharp tip and thereby protecting underlying organs from damage.
- a force which overcomes the spring bias is applied to its distal end, as when the Veress needle is being pushed through a patient's abdominal wall, the inner tube is driven back within the outer cannula, exposing the sharp needle tip.
- a Veress needle of this conventional configuration may be prone to at least the following shortcomings:
- Kulkashi discloses a Veress needle containing a mounted fluid transfer means such as a bobbin that moves out from the proximal end of a distal handle of the device when the needle is penetrating tissue, and that retracts into the handle when the needle has passed through the tissue and the inner tube moves in a distal direction to expose its distal end beyond the sharpened end of the hollow needle.
- the bobbin portion can be manually moved for repetitively retracting and extending the inner tube, in a manner causing the gas exit hole to wipe against an edge of the needle point, theoretically clearing the gas exit hole in the distal end of the inner tube.
- the present application provides answers to some of the mentioned shortcomings of previously available devices, and discloses a safety needle device including similarities to a Veress needle, for emergency treatment of a tension pneumothorax, as defined by the appended claims that form a part of this disclosure.
- An aspect of the safety needle device disclosed herein is that it prevents iatrogenic injury to underlying organs during needle decompression.
- a safety needle includes a mechanism for optionally extending, locking, and unlocking its central tubular stylet.
- a hollow outer cannula is ground obliquely to a sharp point at its distal end, and its proximal end is mounted in a pen-like housing.
- a protective hollow inner tubular stylet Disposed within the outer cannula is a protective hollow inner tubular stylet with a blunt tip at the end common to the sharp tip of the outer cannula, and axially spring-biased via a spring contained in the pen-like housing.
- An indicator in one embodiment of the device disclosed herein allows confirmation of correct needle placement.
- a hollow needle or cannula there is a hollow needle or cannula, and a hollow tube inside the needle, connected with a “pen click” mechanism which allows the sharp point of the device to be exposed or obscured through user action.
- a “pen click” mechanism which allows the sharp point of the device to be exposed or obscured through user action. This allows a user to be sure that the sharp tip of the needle cannot injure tissues when the tip is in the body and the mechanism is locked, and also allows the user to store the used needle without a container without the concern of sharps management.
- such a device has a plunger mechanism for dislodging a tissue plug from the needle. Since this device allows a tissue core to be dislodged, in one embodiment the needle or cannula could be of a fairly large diameter, such as 10 gauge, to assure ample fluid flow for relieving tension pneumothorax.
- a colored indicator is visible through a transparent side portion of the device, showing whether the needle is placed correctly, is not through the chest wall or is plugged with a tissue core.
- FIG. 1 is an isometric view of a medical instrument useful for emergency relief of tension pneumothorax according to the disclosure herein, together with a protective case.
- FIG. 2 is a partially cut-away view of the medical instrument shown in FIG. 1 , taken from the same point of view, showing the protective case removed to expose a sharpened cannula and an associated hollow tubular stylet.
- FIG. 3 is a front elevational view of the medical instrument shown in FIGS. 1 and 2 , at an enlarged scale, with the cannula and tubular stylet shown foreshortened.
- FIG. 4 is a sectional view taken along line 4 - 4 in FIG. 3 .
- FIG. 5 is a sectional view taken along line 5 - 5 in FIG. 3 .
- FIG. 6 is a sectional view similar to FIG. 4 , but showing the medical instrument with the tubular stylet unlocked and able to be displaced into the sharpened end of the cannula.
- FIG. 7 is a front elevational view of the medical instrument shown in FIGS. 1-6 , showing the tubular stylet moved far enough into the cannula to permit use of the instrument to pierce a chest wall of a patient.
- FIG. 8 is a sectional view taken along the line 8 - 8 in FIG. 7 , but showing the instrument with the tubular stylet moved into the cannula to the furthest position available.
- FIG. 9 is a sectional view taken along line 9 - 9 in FIG. 7 .
- FIG. 10 is a sectional view of a device which is a variation of the medical instrument shown in FIGS. 1-7 .
- FIG. 11 is a sectional view of a medical instrument which is a variation of the medical instrument shown in FIG. 10 .
- FIG. 12 is a partially schematic sectional view of a medical instrument which is yet a further variation of the medical instruments shown in FIGS. 1-9 , 10 , and 11 .
- a medical device 10 includes a housing or body 12 to which a generally cylindrical protective outer cover 14 is shown connected in FIG. 1 .
- the cover 14 may be detachably connected to the body 12 as by an externally threaded portion 16 of the body 12 and mating internal threads 18 in the cover 14 .
- Both the body 12 and the cover 14 may be of suitable molded plastic.
- the device 10 may be packaged in a hard protective case for sterilization and protection in an austere prehospital environment.
- a connector such as a female Luer fitting 20
- the body 12 may be generally cylindrical, and defines a slot 24 extending longitudinally along one side near the proximal end 22 .
- the slot 24 pierces the cylindrical wall of the body 12 , extending into the interior of the body 12 , as will be explained more fully presently.
- a crosswise or transverse slot 26 intersects the longitudinal slot 24 near its distal end and extends a short distance on each side of the longitudinal slot 24 .
- a latch release button 28 extends radially outward from the body 12 through the longitudinal slot 24 .
- a hollow needle or cannula 30 extends from the distal end 32 of the body 12 along a central longitudinal axis of the body 12 and has a sharpened, oblique point 34 .
- a hollow inner tube or tubular stylet 36 Disposed within the cannula 30 is a hollow inner tube or tubular stylet 36 that has a blunt distal end or tip 38 and defines an opening 40 located close to the distal tip 38 and extending through the wall of the stylet 36 into its interior bore.
- the bore of the stylet 36 may have an inside diameter 41 of 0.071′′, for example.
- the inner protective tubular stylet 36 continues through the plastic housing 12 and out at the top or proximal end 22 of the body 12 .
- the proximal end 80 of the inner tubular stylet 36 extends into and is secured to the pushbutton 84 , from which the connector or Luer fitting 20 , if included, extends.
- the hollow tubular stylet 36 passes through a helical compression spring 42 with a diameter 44 only slightly larger than the outer diameter 46 of the inner tubular stylet 36 .
- One end of the spring 42 is lodged against the inner face of an end cap 48 closing the proximal end 22 of the body 12 .
- the end cap 48 defines a central opening 49 through which the stylet 36 extends and is free to slide.
- the other end of the spring 42 presses against a carrier, or stylet pusher 50 , slidingly disposed within the body 12 , so that the spring 42 urges the stylet pusher 50 in a distal direction within the interior of the body 12 .
- Another helical compression spring 54 is located within the interior of the body 12 , between the distal end 32 and a distal face 56 of the stylet pusher 50 .
- the spring 54 may have a larger diameter and is a stiffer spring than the spring 42 .
- the spring 54 may be disposed around a cylindrical base or locater 58 extending inward from the distal end of the body 12 and around the stylet 36 , so as to keep the spring 54 centered around the stylet 36 .
- the spring 54 may be fitted tightly around the cylinder 58 , at least at its distal end, or adhesively fastened to the cylinder 58 .
- the stylet pusher 50 is held in a lower or distal location within the interior of the housing or body 12 by a locking mechanism including a pair of arms 60 extending from the latch release button 28 and engaged with a retaining surface 62 within the transverse slot 26 , which functions as a latch receptacle for the arms 60 .
- the spring 54 is compressed and urges the stylet pusher 50 toward the proximal end 22 of the body 12 , keeping the arms 60 of the locking mechanism engaged against retaining surfaces 62 of the proximal side of the transverse slot 26 .
- the body 12 may be molded around the proximal end of the cannula 30 as at 70 , or the cannula 30 may be adhesively secured in the distal end portion 32 of the body 12 .
- the inner tubular stylet 36 is movable axially within the cannula 30 , and the carrier or stylet pusher 50 is fastened to the inner tubular stylet 36 at 74 so as to move together with it, as by being overmolded onto the stylet 26 , or by being adhesively attached to it.
- the latch release button 28 is movable with respect to the remainder of the carrier 50 by flexing the portion 76 , also shown in FIG. 2 , so that the stylet pusher 50 can be inserted into the interior of the body 12 , and then relaxing it to permit the latch release button 28 to protrude through the longitudinal slot 24 , after which the cap 48 can be attached fixedly to the proximal end 22 of the body 12 , where it may be secured adhesively, by ultrasonic welding, or by other suitable means.
- the blunt distal end 38 of the stylet 36 protrudes beyond the sharp point 34 of the cannula 30 , thus obscuring the sharp point 34 and exposing the opening 40 as a pathway for gas to proceed into and through the interior bore of the stylet 36 .
- the locking mechanism is capable of existing in two states, the locked or protective state shown in FIG. 4 , and an unlocked or retracted state as shown in FIGS. 6 , 7 , and 8 .
- the latch release button 28 may be pressed radially inward as shown in FIG. 6 , releasing the arms 60 from engagement against the retaining surfaces 62 , permitting the stylet pusher 50 to move proximally, as urged by the spring 54 , overcoming the force of the spring 42 .
- FIGS. 7 and 8 the latch release button 28 has been released, allowing the flexible portion 76 to return the arms 60 radially outwardly to reside respectively in the grooves 86 , as also shown in FIG.
- the spring 54 is expanded longitudinally nearly to its full length when the arms 60 move proximally beyond their positions of engagement with the surfaces 62 , but the longer, smaller-diameter spring 42 has been compressed slightly more, and urges the carrier 50 in a distal direction, thus keeping the blunt distal end 38 of the stylet 36 protruding slightly beyond the sharp end 34 of the cannula 30 .
- the spring 42 ordinarily urges the stylet pusher 50 , and thus the stylet 36 , to the position shown in FIG. 6 , where its movement in the distal direction is limited by the stronger spring 54 .
- the user penetrates the chest wall with the device 10 .
- the tip 38 is moved in a proximal direction far enough to expose the sharp pointed end 34 of the cannula 30 , as shown in FIG. 7 , and this causes the latch release button 28 to move proximally in the slot 24 .
- the cannula 30 can then cut and pass through the chest wall tissue, and the position of the blunt distal tip 38 can be determined by observation of the position of the latch release button 28 along the longitudinal slot 24 .
- the spring 42 returns the tubular stylet 36 to its extended position, shielding underlying organs from the sharp pointed tip 34 of the outer cannula 30 .
- the user observing the return of the stylet 36 to its extended position, can then press on the pushbutton 84 , or the latch release button 28 , moving the stylet pusher 50 against the force of the spring 54 and camming the arms 60 against the interior of the body 12 . This flexes the portion 76 to engage the arms 60 in the crosswise slot 26 , placing the device 10 into the locked, safe, condition.
- a locking mechanism can thus be engaged to hold the protective tubular stylet 36 extended, keeping the blunt tip 38 exposed and obscuring the sharp tip 34 .
- the needle could then be left in place without fear of the spring biased protective blunt tip retracting if forced into contact with underlying organs.
- the connector 20 shown in FIGS. 1-7 may be used to receive a Luer fitting including a check valve allowing air and other fluids to be expelled from within a patient's body cavity via the opening 40 near the blunt tip end 38 and through the interior bore of the inner tube 36 but preventing an open pneumothorax condition from being formed by use of the device 10 .
- An appropriate fitting for a flexible tube may also be attached to the connector 20 as a conduit to provide insufflating gas for use of the device 10 in connection with laparoscopic surgery.
- the blunt distal end 38 of the inner tube or stylet 36 is located fully within the bore of the cannula 30 , and the stylet pusher 50 is in its furthest available proximal position within the interior of the body 12 , as might result from intrusion of a plug of tissue into the bore of the cannula 30 and pushing the blunt tip 38 .
- the pusher 50 has compressed the spring 42 and carried the latch release button 28 to the proximal end of the longitudinal slot 24 , allowing the spring 54 to extend itself fully in a proximal direction from the distal end 32 of the body 12 .
- This results in the pushbutton 84 and Luer fitting 20 attached to the proximal end 80 of the stylet 36 , being moved in a proximal direction away from the end cap 48 .
- the locking mechanism can be released when that is desired, by pressing on the latch release button 28 to disengage the arms 60 from the retaining surfaces 62 of the transverse slot 26 .
- a safety decompression needle 10 has distinct advantages over a Veress needle of the conventional configuration:
- a device 90 that is a variation of the device 10 shown in FIGS. 1-9 includes generally cylindrical, pen-like body 94 with a window 92 of transparent material through which the operator may view the inner tubular stylet 36 .
- a cannula 30 is mounted in a manner similar to the attachment of the cannula 30 to the distal end portion 32 of the body 12 of the device 10 .
- a partition 98 defines a cavity 99 within the distal end portion of the body 94 .
- a colored washer-like collar, or bobber, 100 is securely attached to the tubular stylet 36 within the cavity 99 and functions as a stylet pusher, so that when the force of a helical compression spring 102 , surrounding the stylet 36 and extending between the partition 98 and the stylet pusher bobber 100 , is overcome, and the sharpened tip end 34 of the outer cannula 30 is exposed, the colored stylet pushing collar 100 is visible to the user through the window 92 .
- the location and size of the window 92 may be designed to make the stylet pusher collar 100 visible with the blunt end 38 in a desired position or range of positions with respect to the sharpened tip 34 of the cannula 30 .
- the inner tubular stylet 36 is fully extended, with its blunt end 38 extending beyond the sharpened outer tip 34 of the cannula 30 , and the stylet pusher collar 100 is not visible to the operator, but is located within an opaque portion of the body 94 .
- the inner tubular stylet 36 extends through the partition 98 , and is movable within a bore 118 defined in a pushbutton 104 , shown latched in a locked position with respect to the body 94 , in which the pushbutton 104 acts as a positively engaged style pusher and keeps the inner tubular stylet 36 extended with its blunt end 38 protruding beyond the sharpened end 34 of the cannula 30 .
- a catch 106 carried on a resiliently flexible finger portion 108 of the pushbutton 104 is engaged in a distal catch receptacle 110 .
- the engagement of the proximal end 80 of the inner tube or stylet 36 , against a seat within the bore 118 in the pushbutton 104 keeps the stylet 36 extended to the position shown in FIG. 10 in which its outer blunt end 38 extends beyond the sharpened distal tip 34 of the outer cannula 30 , preventing the sharpened tip 34 from puncturing tissues.
- the catch 106 can be released from the receptacle 110 by pushing a latch release button 111 inward in a slot 113 in the body 94 , flexing the finger 108 .
- Another helical compression spring 112 is located within the body 94 , between the proximal side of the partition 98 and the distal end 114 , or base, of the pushbutton 104 , urging the pushbutton 104 in a proximal direction, within the body 94 , that is, upward in FIG. 10 .
- the catch 106 is normally engaged in a proximal catch receptacle 116 , and the spring 112 extends by virtue of its own elasticity, urging the pushbutton 104 in a distal direction to keep the catch 106 engaged in the proximal catch receptacle 116 , as with the pushbutton 128 shown in FIG. 11 .
- the pushbutton 104 With the pushbutton 104 not in the locked position shown in FIG.
- the inner tube or stylet 36 is free to move longitudinally within the bore 118 defined centrally and extending longitudinally through the pushbutton 104 , with the proximal end 80 movable within the bore 118 between the position shown in solid line and the position shown in broken line, as the stylet 36 is urged by the spring 102 or pressure on the blunt end 38 .
- the spring 102 will push the collar or stylet pusher 100 in a distal direction to the distal end of the cavity 99 , thus moving the stylet 36 in the distal direction and causing the blunt distal end 38 to protrude as shown in FIG. 10 .
- the colored stylet pusher 100 in its spring-biased position in the cavity 99 , is then hidden, obscured by an opaque portion of the plastic housing and indicating to the user that successful placement of the cannula 30 has been made.
- the colored stylet pusher 100 remains visible through the window 92 .
- the user may then press on the pushbutton 104 extending from the top or proximal end of the plastic body 94 , thus dislodging the tissue core. If the colored stylet pusher 100 is visible in the window 92 , revealing that the blunt tip 38 is retracted within the sharp cannula 30 , the user might not know whether this is due to a tissue core plug or whether the needle or cannula 30 has not penetrated completely through the chest wall. In this case, the pushbutton 104 can be pushed. If what is judged to be enough force doesn't move the colored stylet pusher 100 out of sight, the chest wall has likely not been penetrated.
- the pushbutton 104 may be pushed to the position shown in FIG. 10 to place the device in the locked state, preventing the sharpened end 34 from further cutting or piercing an internal organ unintentionally.
- a device 124 is similar in many respects to the device 90 .
- a body 126 is similar in many respects to the body 94
- a pushbutton 128 is similar in most respects to the pushbutton 104 of the device 90 , but the pushbutton 128 of the mechanism of the housing 126 includes a colored collar or layer 130 .
- the locking mechanism is engaged holding the pushbutton 128 in the locked configuration (protracted state), with the pushbutton 128 in a distal location similar to that of the pushbutton 104 as shown in FIG. 10 , the colored collar or layer 130 is not visible.
- the locking mechanism is not engaged and the pushbutton 128 is in the retracted state, as shown in FIG.
- the colored band 130 is visible through a transparent portion 132 of the body 126 and the spring 112 is extended, keeping the pushbutton 128 in its retracted, proximal position as shown in FIG. 11 with the catch 106 in the proximal latch receptacle 116 of the housing, or body 126 .
- the locking mechanism is in the retracted state as shown in FIG. 11 , with the colored band 130 visible, the user can conclude that the sharp tip 34 may be exposed and cannot be assumed to be obscured by the blunt end 38 of the tubular stylet 36 .
- the collar or stylet pusher 100 securely attached to the inner tube or stylet 36 , is normally urged by the spring 102 toward a distally located, extended position in which the blunt outer tip 38 of the stylet 36 extends beyond the sharpened outer end 34 of the cannula 30 .
- the inner tube or stylet 36 With the pushbutton 128 in its proximally located retracted position, however, the inner tube or stylet 36 is free to move axially except as urged in a distal direction by the spring 102 , so that the stylet 36 may be pushed inward as the device 124 is pushed through a patient's chest wall, and the sharpened end 34 of the cannula 30 is exposed and able to pierce the chest wall.
- the proximal end 80 of the inner tube or stylet 36 is free to move axially within the bore 118 defined within the pushbutton 128 as the spring 102 is compressed and the inner tube of stylet 36 is urged into and along the interior of the bore of the cannula 30 between the position shown in broken line and the position shown in solid line.
- a connector such as the Luer fitting receptacle 20 could be included at the proximal end of the pushbutton 104 or 128 .
- a device similar to a combination of the devices 90 and 124 might include all of the colored collar 100 , the viewing window 92 , the viewing window 132 , and the colored band or collar 130 , so that the user might discern both that the inner tube or stylet 36 is free to move, as indicated by alignment of the colored band 130 with the viewing window 132 , and that the inner tube or stylet 36 may have been forced into the bore of the outer cannula, if the collar 100 is seen to be aligned with the viewing window 92 .
- another emergency chest decompression device 140 intended for use in relieving a tension pneumothorax may be generally similar to the devices 90 and 124 shown in FIGS. 10 and 11 but may include a different locking mechanism 142 , shown schematically within a body 144 and operable by a pushbutton 146 .
- a spacer or core 148 defining a space for inclusion of the locking mechanism 142 and acting as a retainer for the proximal end of the spring 102 acting on the collar 100 to urge the inner tube or stylet 36 in a distal direction as in the devices described above and shown in FIGS. 10 and 11 .
- the mechanism 142 may be disposed around the stylet 36 , and a loose fit of or a passage through the pushbutton 146 may allow passage of fluid via the stylet 36 .
- One specific type of locking mechanism is exemplified by standard pushbutton retractable pen tip mechanism, such as the mechanism disclosed in Snell et al. (U.S. Pat. No. 4,991,988) in which a spring biases two small sets of cams together, and the user is able to extend and lock the pen tip and thereafter release it by repeatedly depressing the pushbutton on the head of a pen. Depressing the pushbutton moves the cams along the pen's long axis, guided by grooves internal to the pen body. The cams rotate with respect to each other and create two discrete pen phases: extended (locked), and retracted (unlocked).
- a base piece of the mechanism 142 is moved farther away from the proximally terminating end of the inner tubular stylet 36 , allowing it to be moved into the cannula 30 .
- the base piece moves closer to and ideally abuts against the proximally terminating end of the inner tubular stylet 36 .
- blunt-ended tubular stylet 36 also has two possible states:
- the stylet 36 is free to travel inward along the longitudinal axis of the outer cannula 30 provided that a force great enough in magnitude to overcome the force of the spring 102 also exists.
- the base piece when the locking mechanism 142 exists in the locked, or protracted, state, the base piece ideally abuts against the proximally terminating end of the tubular stylet 36 . This prevents the inner tubular stylet 36 from moving with respect to the outer cannula 30 , regardless of the magnitude of force applied to the distal end 38 of the inner tubular stylet 36 .
- a further feature of the invention could be a locking mechanism which prevents accidental triggering of the pen click feature.
- the mechanism that releases the device to its sharp activated mode could have a removable cover, a slide that covers the release mechanism, a hinged door that reversibly covers the release mechanism, or one of a number of other protective mechanisms.
Abstract
Description
- The present invention relates to treatment of medical conditions such as tension pneumothorax and particularly to a device for its treatment.
- The U.S. military services currently prescribe needle decompression for treatment of tension pneumothorax, a condition which can be fatal if not quickly relieved. The means of treatment for prehospital care should be compact and as simple as practical.
- The needle prescribed by the military services is sharp, creating the possibility of damaging underlying organs after initial penetration through the chest wall. It has been reported as well that the needle occasionally plugs with a tissue “core” as it travels through the chest wall. If the plug is detected, the needle could be flushed using a syringe; however it is not certain that the plug would be detected. A 3.15 inch long, 14 gauge angiocatheter needle is used as the standard of care for the U.S. military. Although the catheter is 14 gauge (0.083″ diameter), the inner diameter is 0.058″, and the needle outer and inner diameters are 0.058″ and 0.042″ respectively. This small inner diameter of 0.042″ does not provide an effective means for venting pressurized air quickly from the pleural space. Removal of the needle, leaving the catheter in place, allows better flow, but is not desired, since if it were left in place for long periods it would in essence be an open pneumothorax, and because the catheter is likely to kink and close itself off. The military has considered adopting a 10 gauge needle (outer diameter 0.134″=3.404 mm, inner diameter 0.106″=2.692 mm) to permit greater flow, but it has been found that a larger gauge needle has more propensity to clog with a tissue core.
- The Veress needle is a special needle used in laparoscopic surgical procedures. A conventional Veress needle consists of a hollow outer cannula ground obliquely to a sharp point at a distal end, and terminating in a plastic housing at the opposite proximal end. Enclosed within the outer cannula is a hollow tube that has a blunt tip at its distal end (common to the sharp tip of the outer cannula), and that is axially spring-biased in a distal direction by a spring contained in the plastic housing. When no force is applied to the distal end to resist the penetrating point, the spring bias forces the hollow inner tube to protrude just beyond the sharp tip of the outer cannula, obscuring the sharp tip and thereby protecting underlying organs from damage. When a force which overcomes the spring bias is applied to its distal end, as when the Veress needle is being pushed through a patient's abdominal wall, the inner tube is driven back within the outer cannula, exposing the sharp needle tip.
- A Veress needle of this conventional configuration may be prone to at least the following shortcomings:
-
- (1) Such a needle may not adequately protect a patient if, when the needle is introduced subcutaneously in the vicinity of vital organs (which is often the case), there is a force of sufficient magnitude to overcome the spring bias of the inner tube and thus expose the outer cannula's sharp tip.
- (2) Such a needle may be prone to clogging, as the generally weak spring bias may be insufficient to overcome the resistive forces of tissue or blood which then may become wedged within the hollow outer cannula.
- (3) The sharp tip of the Veress needle after use is another potential danger on the battlefield and is a challenge for the military.
- Kulkashi (U.S. Pat. No. 5,098,388) discloses a Veress needle containing a mounted fluid transfer means such as a bobbin that moves out from the proximal end of a distal handle of the device when the needle is penetrating tissue, and that retracts into the handle when the needle has passed through the tissue and the inner tube moves in a distal direction to expose its distal end beyond the sharpened end of the hollow needle. The bobbin portion can be manually moved for repetitively retracting and extending the inner tube, in a manner causing the gas exit hole to wipe against an edge of the needle point, theoretically clearing the gas exit hole in the distal end of the inner tube.
- The present application provides answers to some of the mentioned shortcomings of previously available devices, and discloses a safety needle device including similarities to a Veress needle, for emergency treatment of a tension pneumothorax, as defined by the appended claims that form a part of this disclosure.
- An aspect of the safety needle device disclosed herein is that it prevents iatrogenic injury to underlying organs during needle decompression.
- In one embodiment of the device disclosed herein, a safety needle includes a mechanism for optionally extending, locking, and unlocking its central tubular stylet.
- One embodiment of the device disclosed herein can incorporate one of many various “retracting pen” mechanisms. In such a configuration, a hollow outer cannula is ground obliquely to a sharp point at its distal end, and its proximal end is mounted in a pen-like housing. Disposed within the outer cannula is a protective hollow inner tubular stylet with a blunt tip at the end common to the sharp tip of the outer cannula, and axially spring-biased via a spring contained in the pen-like housing.
- An indicator in one embodiment of the device disclosed herein allows confirmation of correct needle placement.
- In one embodiment, there is a hollow needle or cannula, and a hollow tube inside the needle, connected with a “pen click” mechanism which allows the sharp point of the device to be exposed or obscured through user action. This allows a user to be sure that the sharp tip of the needle cannot injure tissues when the tip is in the body and the mechanism is locked, and also allows the user to store the used needle without a container without the concern of sharps management.
- In one embodiment, such a device has a plunger mechanism for dislodging a tissue plug from the needle. Since this device allows a tissue core to be dislodged, in one embodiment the needle or cannula could be of a fairly large diameter, such as 10 gauge, to assure ample fluid flow for relieving tension pneumothorax.
- In one embodiment, a colored indicator is visible through a transparent side portion of the device, showing whether the needle is placed correctly, is not through the chest wall or is plugged with a tissue core.
- The foregoing and other objectives and features of the invention will be more readily understood upon consideration of the following detailed description of the embodiments taken in conjunction with the accompanying drawings.
-
FIG. 1 is an isometric view of a medical instrument useful for emergency relief of tension pneumothorax according to the disclosure herein, together with a protective case. -
FIG. 2 is a partially cut-away view of the medical instrument shown inFIG. 1 , taken from the same point of view, showing the protective case removed to expose a sharpened cannula and an associated hollow tubular stylet. -
FIG. 3 is a front elevational view of the medical instrument shown inFIGS. 1 and 2 , at an enlarged scale, with the cannula and tubular stylet shown foreshortened. -
FIG. 4 is a sectional view taken along line 4-4 inFIG. 3 . -
FIG. 5 is a sectional view taken along line 5-5 inFIG. 3 . -
FIG. 6 is a sectional view similar toFIG. 4 , but showing the medical instrument with the tubular stylet unlocked and able to be displaced into the sharpened end of the cannula. -
FIG. 7 is a front elevational view of the medical instrument shown inFIGS. 1-6 , showing the tubular stylet moved far enough into the cannula to permit use of the instrument to pierce a chest wall of a patient. -
FIG. 8 is a sectional view taken along the line 8-8 inFIG. 7 , but showing the instrument with the tubular stylet moved into the cannula to the furthest position available. -
FIG. 9 is a sectional view taken along line 9-9 inFIG. 7 . -
FIG. 10 is a sectional view of a device which is a variation of the medical instrument shown inFIGS. 1-7 . -
FIG. 11 is a sectional view of a medical instrument which is a variation of the medical instrument shown inFIG. 10 . -
FIG. 12 is a partially schematic sectional view of a medical instrument which is yet a further variation of the medical instruments shown inFIGS. 1-9 , 10, and 11. - Referring to the drawings which form a part of the disclosure herein, and referring first to
FIGS. 1 and 2 , amedical device 10 includes a housing orbody 12 to which a generally cylindrical protectiveouter cover 14 is shown connected inFIG. 1 . Thecover 14 may be detachably connected to thebody 12 as by an externally threadedportion 16 of thebody 12 and matinginternal threads 18 in thecover 14. Both thebody 12 and thecover 14 may be of suitable molded plastic. Thedevice 10 may be packaged in a hard protective case for sterilization and protection in an austere prehospital environment. - A connector, such as a female Luer fitting 20, may be provided at the
proximal end 22 of thebody 12, the top end as shown inFIGS. 1 and 2 . Thebody 12 may be generally cylindrical, and defines aslot 24 extending longitudinally along one side near theproximal end 22. Theslot 24 pierces the cylindrical wall of thebody 12, extending into the interior of thebody 12, as will be explained more fully presently. A crosswise ortransverse slot 26 intersects thelongitudinal slot 24 near its distal end and extends a short distance on each side of thelongitudinal slot 24. Alatch release button 28 extends radially outward from thebody 12 through thelongitudinal slot 24. - As shown in
FIG. 2 , a hollow needle orcannula 30 extends from thedistal end 32 of thebody 12 along a central longitudinal axis of thebody 12 and has a sharpened,oblique point 34. - Disposed within the
cannula 30 is a hollow inner tube ortubular stylet 36 that has a blunt distal end ortip 38 and defines anopening 40 located close to thedistal tip 38 and extending through the wall of thestylet 36 into its interior bore. With acannula 30 of 10 gauge size, the bore of thestylet 36 may have an inside diameter 41 of 0.071″, for example. - Referring now also to
FIGS. 3 and 4 , the inner protectivetubular stylet 36 continues through theplastic housing 12 and out at the top orproximal end 22 of thebody 12. Theproximal end 80 of the innertubular stylet 36 extends into and is secured to thepushbutton 84, from which the connector or Luer fitting 20, if included, extends. Within thebody 12, the hollowtubular stylet 36 passes through ahelical compression spring 42 with adiameter 44 only slightly larger than theouter diameter 46 of the innertubular stylet 36. One end of thespring 42 is lodged against the inner face of anend cap 48 closing theproximal end 22 of thebody 12. Theend cap 48 defines acentral opening 49 through which thestylet 36 extends and is free to slide. The other end of thespring 42 presses against a carrier, orstylet pusher 50, slidingly disposed within thebody 12, so that thespring 42 urges thestylet pusher 50 in a distal direction within the interior of thebody 12. Anotherhelical compression spring 54 is located within the interior of thebody 12, between thedistal end 32 and adistal face 56 of thestylet pusher 50. Thespring 54 may have a larger diameter and is a stiffer spring than thespring 42. Thespring 54 may be disposed around a cylindrical base orlocater 58 extending inward from the distal end of thebody 12 and around thestylet 36, so as to keep thespring 54 centered around thestylet 36. Thespring 54 may be fitted tightly around thecylinder 58, at least at its distal end, or adhesively fastened to thecylinder 58. - As shown in
FIG. 4 , thestylet pusher 50 is held in a lower or distal location within the interior of the housing orbody 12 by a locking mechanism including a pair ofarms 60 extending from thelatch release button 28 and engaged with a retainingsurface 62 within thetransverse slot 26, which functions as a latch receptacle for thearms 60. With thestylet pusher 50 in that position, thespring 54 is compressed and urges thestylet pusher 50 toward theproximal end 22 of thebody 12, keeping thearms 60 of the locking mechanism engaged against retaining surfaces 62 of the proximal side of thetransverse slot 26. - The
body 12 may be molded around the proximal end of thecannula 30 as at 70, or thecannula 30 may be adhesively secured in thedistal end portion 32 of thebody 12. The innertubular stylet 36 is movable axially within thecannula 30, and the carrier orstylet pusher 50 is fastened to the innertubular stylet 36 at 74 so as to move together with it, as by being overmolded onto thestylet 26, or by being adhesively attached to it. - As may be seen in
FIGS. 4 and 6 , thelatch release button 28 is movable with respect to the remainder of thecarrier 50 by flexing theportion 76, also shown inFIG. 2 , so that thestylet pusher 50 can be inserted into the interior of thebody 12, and then relaxing it to permit thelatch release button 28 to protrude through thelongitudinal slot 24, after which thecap 48 can be attached fixedly to theproximal end 22 of thebody 12, where it may be secured adhesively, by ultrasonic welding, or by other suitable means. - In the condition shown in
FIG. 4 , with the carrier orstylet pusher 50 latched in its furthest distal position, the bluntdistal end 38 of thestylet 36 protrudes beyond thesharp point 34 of thecannula 30, thus obscuring thesharp point 34 and exposing theopening 40 as a pathway for gas to proceed into and through the interior bore of thestylet 36. - The locking mechanism is capable of existing in two states, the locked or protective state shown in
FIG. 4 , and an unlocked or retracted state as shown inFIGS. 6 , 7, and 8. Beginning locked as shown inFIG. 4 , thelatch release button 28 may be pressed radially inward as shown inFIG. 6 , releasing thearms 60 from engagement against the retaining surfaces 62, permitting thestylet pusher 50 to move proximally, as urged by thespring 54, overcoming the force of thespring 42. As shown inFIGS. 7 and 8 thelatch release button 28 has been released, allowing theflexible portion 76 to return thearms 60 radially outwardly to reside respectively in thegrooves 86, as also shown inFIG. 9 , on each side of thelongitudinal slot 24. As may be seen inFIG. 6 , thespring 54 is expanded longitudinally nearly to its full length when thearms 60 move proximally beyond their positions of engagement with thesurfaces 62, but the longer, smaller-diameter spring 42 has been compressed slightly more, and urges thecarrier 50 in a distal direction, thus keeping the bluntdistal end 38 of thestylet 36 protruding slightly beyond thesharp end 34 of thecannula 30. - When the
latch release button 28 is not locked with thearms 60 in thecrosswise slot 26, thespring 42 ordinarily urges thestylet pusher 50, and thus thestylet 36, to the position shown inFIG. 6 , where its movement in the distal direction is limited by thestronger spring 54. - To relieve a tension pneumothorax, the user penetrates the chest wall with the
device 10. When thedecompression needle 10 is being urged through a chest wall or abdominal wall thetip 38 is moved in a proximal direction far enough to expose the sharppointed end 34 of thecannula 30, as shown inFIG. 7 , and this causes thelatch release button 28 to move proximally in theslot 24. Thecannula 30 can then cut and pass through the chest wall tissue, and the position of the bluntdistal tip 38 can be determined by observation of the position of thelatch release button 28 along thelongitudinal slot 24. Once the chest wall has been penetrated, thespring 42 returns thetubular stylet 36 to its extended position, shielding underlying organs from the sharppointed tip 34 of theouter cannula 30. The user, observing the return of thestylet 36 to its extended position, can then press on thepushbutton 84, or thelatch release button 28, moving thestylet pusher 50 against the force of thespring 54 and camming thearms 60 against the interior of thebody 12. This flexes theportion 76 to engage thearms 60 in thecrosswise slot 26, placing thedevice 10 into the locked, safe, condition. - Once the
chest decompression device 10 is in place, a locking mechanism can thus be engaged to hold the protectivetubular stylet 36 extended, keeping theblunt tip 38 exposed and obscuring thesharp tip 34. The needle could then be left in place without fear of the spring biased protective blunt tip retracting if forced into contact with underlying organs. - The
connector 20 shown inFIGS. 1-7 may be used to receive a Luer fitting including a check valve allowing air and other fluids to be expelled from within a patient's body cavity via theopening 40 near theblunt tip end 38 and through the interior bore of theinner tube 36 but preventing an open pneumothorax condition from being formed by use of thedevice 10. An appropriate fitting for a flexible tube may also be attached to theconnector 20 as a conduit to provide insufflating gas for use of thedevice 10 in connection with laparoscopic surgery. - As shown in
FIG. 8 , the bluntdistal end 38 of the inner tube orstylet 36 is located fully within the bore of thecannula 30, and thestylet pusher 50 is in its furthest available proximal position within the interior of thebody 12, as might result from intrusion of a plug of tissue into the bore of thecannula 30 and pushing theblunt tip 38. Thepusher 50 has compressed thespring 42 and carried thelatch release button 28 to the proximal end of thelongitudinal slot 24, allowing thespring 54 to extend itself fully in a proximal direction from thedistal end 32 of thebody 12. This results in thepushbutton 84 and Luer fitting 20, attached to theproximal end 80 of thestylet 36, being moved in a proximal direction away from theend cap 48. - The locking mechanism can be released when that is desired, by pressing on the
latch release button 28 to disengage thearms 60 from the retaining surfaces 62 of thetransverse slot 26. Once thedevice 10 has been used, it can be placed into the locked, protracted state, providing safety from sharps danger in a simple yet reliable manner particularly valuable in non-hospital situations such as military environments. - A
safety decompression needle 10 has distinct advantages over a Veress needle of the conventional configuration: -
- (1) By placing the inner
tubular stylet 36 into the protracted state and engaging the locking mechanism, the innertubular stylet 36 is prevented from retracting, and thus thesharp tip 34 of theouter cannula 30 cannot be exposed. This prevents inadvertent puncture of internal organs or other tissues. - (2) When the user determines that a clog exists within the
cannula 30, but the bias of thespring 42 on the innertubular stylet 36 is insufficient to overcome the resistance of the impacted tissue or blood, the user can press on thepushbutton 84, urging it, thestylet pusher 50, and thestylet 36 in a distal direction as a plunger. With the added force, thestylet 36 would likely overcome the resistive forces of the wedged tissue, dislodging the clog. To keep thestylet 36 protracted, the locking mechanism can then be engaged by moving thepushbutton 84 further. As thearms 60 approach thecrosswise slot 26, inclined cam surfaces 64 urge them inward, flexing theflexible portion 76 of thestylet pusher 50 inward until thearms 60 move in a distal direction far enough to move resiliently outward into thecrosswise slot 26 and come to bear on the retaining surfaces 62. - (3) When the
device 10 is locked in the protracted state, thesharp end 34 is safe without a separate cover.
- (1) By placing the inner
- Referring to
FIG. 10 , adevice 90 that is a variation of thedevice 10 shown inFIGS. 1-9 includes generally cylindrical, pen-like body 94 with awindow 92 of transparent material through which the operator may view the innertubular stylet 36. In adistal end portion 96 of thebody 94, acannula 30 is mounted in a manner similar to the attachment of thecannula 30 to thedistal end portion 32 of thebody 12 of thedevice 10. Apartition 98 defines acavity 99 within the distal end portion of thebody 94. A colored washer-like collar, or bobber, 100, is securely attached to thetubular stylet 36 within thecavity 99 and functions as a stylet pusher, so that when the force of ahelical compression spring 102, surrounding thestylet 36 and extending between thepartition 98 and thestylet pusher bobber 100, is overcome, and the sharpenedtip end 34 of theouter cannula 30 is exposed, the coloredstylet pushing collar 100 is visible to the user through thewindow 92. The location and size of thewindow 92 may be designed to make thestylet pusher collar 100 visible with theblunt end 38 in a desired position or range of positions with respect to the sharpenedtip 34 of thecannula 30. - As shown in
FIG. 10 , however, the innertubular stylet 36 is fully extended, with itsblunt end 38 extending beyond the sharpenedouter tip 34 of thecannula 30, and thestylet pusher collar 100 is not visible to the operator, but is located within an opaque portion of thebody 94. - As shown in
FIG. 10 , the innertubular stylet 36 extends through thepartition 98, and is movable within abore 118 defined in apushbutton 104, shown latched in a locked position with respect to thebody 94, in which thepushbutton 104 acts as a positively engaged style pusher and keeps the innertubular stylet 36 extended with itsblunt end 38 protruding beyond the sharpenedend 34 of thecannula 30. - A
catch 106 carried on a resilientlyflexible finger portion 108 of thepushbutton 104 is engaged in adistal catch receptacle 110. With thepushbutton 104 so latched, the engagement of theproximal end 80 of the inner tube orstylet 36, against a seat within thebore 118 in thepushbutton 104 keeps thestylet 36 extended to the position shown inFIG. 10 in which its outerblunt end 38 extends beyond the sharpeneddistal tip 34 of theouter cannula 30, preventing the sharpenedtip 34 from puncturing tissues. Thecatch 106 can be released from thereceptacle 110 by pushing alatch release button 111 inward in aslot 113 in thebody 94, flexing thefinger 108. - Another
helical compression spring 112 is located within thebody 94, between the proximal side of thepartition 98 and thedistal end 114, or base, of thepushbutton 104, urging thepushbutton 104 in a proximal direction, within thebody 94, that is, upward inFIG. 10 . When thepushbutton 104 is not latched in the locked position as shown inFIG. 10 , thecatch 106 is normally engaged in aproximal catch receptacle 116, and thespring 112 extends by virtue of its own elasticity, urging thepushbutton 104 in a distal direction to keep thecatch 106 engaged in theproximal catch receptacle 116, as with thepushbutton 128 shown inFIG. 11 . With thepushbutton 104 not in the locked position shown inFIG. 10 the inner tube orstylet 36 is free to move longitudinally within thebore 118 defined centrally and extending longitudinally through thepushbutton 104, with theproximal end 80 movable within thebore 118 between the position shown in solid line and the position shown in broken line, as thestylet 36 is urged by thespring 102 or pressure on theblunt end 38. - Ordinarily, when the
cannula 30 of thedevice 90 is not being urged through tissue by a user, thespring 102 will push the collar orstylet pusher 100 in a distal direction to the distal end of thecavity 99, thus moving thestylet 36 in the distal direction and causing the bluntdistal end 38 to protrude as shown inFIG. 10 . Thecolored stylet pusher 100, in its spring-biased position in thecavity 99, is then hidden, obscured by an opaque portion of the plastic housing and indicating to the user that successful placement of thecannula 30 has been made. - However, if during penetration of the chest wall the
cannula 36 has become occluded with a tissue plug and the protectivetubular stylet 36 is thus kept within theouter cannula 30, thecolored stylet pusher 100 remains visible through thewindow 92. The user may then press on thepushbutton 104 extending from the top or proximal end of theplastic body 94, thus dislodging the tissue core. If thecolored stylet pusher 100 is visible in thewindow 92, revealing that theblunt tip 38 is retracted within thesharp cannula 30, the user might not know whether this is due to a tissue core plug or whether the needle orcannula 30 has not penetrated completely through the chest wall. In this case, thepushbutton 104 can be pushed. If what is judged to be enough force doesn't move thecolored stylet pusher 100 out of sight, the chest wall has likely not been penetrated. - Once the user concludes that the sharpened
end 34 of the outer cannula has passed through the chest wall, as when thecolored stylet pusher 100 disappears, thepushbutton 104 may be pushed to the position shown inFIG. 10 to place the device in the locked state, preventing the sharpenedend 34 from further cutting or piercing an internal organ unintentionally. - Referring next to
FIG. 11 , adevice 124 is similar in many respects to thedevice 90. Abody 126 is similar in many respects to thebody 94, and apushbutton 128 is similar in most respects to thepushbutton 104 of thedevice 90, but thepushbutton 128 of the mechanism of thehousing 126 includes a colored collar orlayer 130. When the locking mechanism is engaged holding thepushbutton 128 in the locked configuration (protracted state), with thepushbutton 128 in a distal location similar to that of thepushbutton 104 as shown inFIG. 10 , the colored collar orlayer 130 is not visible. When the locking mechanism is not engaged and thepushbutton 128 is in the retracted state, as shown inFIG. 11 , thecolored band 130 is visible through atransparent portion 132 of thebody 126 and thespring 112 is extended, keeping thepushbutton 128 in its retracted, proximal position as shown inFIG. 11 with thecatch 106 in theproximal latch receptacle 116 of the housing, orbody 126. When the locking mechanism is in the retracted state as shown inFIG. 11 , with thecolored band 130 visible, the user can conclude that thesharp tip 34 may be exposed and cannot be assumed to be obscured by theblunt end 38 of thetubular stylet 36. - As shown in
FIG. 11 , the collar orstylet pusher 100, securely attached to the inner tube orstylet 36, is normally urged by thespring 102 toward a distally located, extended position in which the bluntouter tip 38 of thestylet 36 extends beyond the sharpenedouter end 34 of thecannula 30. With thepushbutton 128 in its proximally located retracted position, however, the inner tube orstylet 36 is free to move axially except as urged in a distal direction by thespring 102, so that thestylet 36 may be pushed inward as thedevice 124 is pushed through a patient's chest wall, and the sharpenedend 34 of thecannula 30 is exposed and able to pierce the chest wall. Theproximal end 80 of the inner tube orstylet 36 is free to move axially within thebore 118 defined within thepushbutton 128 as thespring 102 is compressed and the inner tube ofstylet 36 is urged into and along the interior of the bore of thecannula 30 between the position shown in broken line and the position shown in solid line. - A connector such as the
Luer fitting receptacle 20 could be included at the proximal end of thepushbutton - It will be understood by the reader that a device similar to a combination of the
devices colored collar 100, theviewing window 92, theviewing window 132, and the colored band orcollar 130, so that the user might discern both that the inner tube orstylet 36 is free to move, as indicated by alignment of thecolored band 130 with theviewing window 132, and that the inner tube orstylet 36 may have been forced into the bore of the outer cannula, if thecollar 100 is seen to be aligned with theviewing window 92. - As shown in
FIG. 12 , another emergencychest decompression device 140 intended for use in relieving a tension pneumothorax may be generally similar to thedevices FIGS. 10 and 11 but may include adifferent locking mechanism 142, shown schematically within abody 144 and operable by apushbutton 146. Within thebody 144, there may be a spacer orcore 148 defining a space for inclusion of thelocking mechanism 142 and acting as a retainer for the proximal end of thespring 102 acting on thecollar 100 to urge the inner tube orstylet 36 in a distal direction as in the devices described above and shown inFIGS. 10 and 11 . Themechanism 142 may be disposed around thestylet 36, and a loose fit of or a passage through thepushbutton 146 may allow passage of fluid via thestylet 36. - One specific type of locking mechanism is exemplified by standard pushbutton retractable pen tip mechanism, such as the mechanism disclosed in Snell et al. (U.S. Pat. No. 4,991,988) in which a spring biases two small sets of cams together, and the user is able to extend and lock the pen tip and thereafter release it by repeatedly depressing the pushbutton on the head of a pen. Depressing the pushbutton moves the cams along the pen's long axis, guided by grooves internal to the pen body. The cams rotate with respect to each other and create two discrete pen phases: extended (locked), and retracted (unlocked).
- In the retracted state, a base piece of the
mechanism 142 is moved farther away from the proximally terminating end of the innertubular stylet 36, allowing it to be moved into thecannula 30. - In the locked, or protracted, state, the base piece moves closer to and ideally abuts against the proximally terminating end of the inner
tubular stylet 36. - Thus, the blunt-ended
tubular stylet 36 also has two possible states: - First, when the
locking mechanism 142 exists in the retracted state, thestylet 36 is free to travel inward along the longitudinal axis of theouter cannula 30 provided that a force great enough in magnitude to overcome the force of thespring 102 also exists. - Second, when the
locking mechanism 142 exists in the locked, or protracted, state, the base piece ideally abuts against the proximally terminating end of thetubular stylet 36. This prevents the innertubular stylet 36 from moving with respect to theouter cannula 30, regardless of the magnitude of force applied to thedistal end 38 of the innertubular stylet 36. - A further feature of the invention could be a locking mechanism which prevents accidental triggering of the pen click feature. The mechanism that releases the device to its sharp activated mode could have a removable cover, a slide that covers the release mechanism, a hinged door that reversibly covers the release mechanism, or one of a number of other protective mechanisms.
- The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.
Claims (12)
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